RecruitingNot ApplicableNCT07328698

Postoperative Ozonated Oil Dressing After Open Inguinal Hernia Repair: A Randomized Pilot Trial

Effect of Postoperative Ozonated Oil Dressing on Early Wound Inflammation After Open Mesh Inguinal Hernia Repair: A Prospective Randomized Pilot Controlled Trial


Sponsor

Nigde Omer Halisdemir University

Enrollment

60 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study looks at whether a special wound dressing containing ozonated oil can reduce early wound inflammation after open inguinal hernia surgery. Open inguinal hernia repair is a common operation, and although infection rates are low, many patients experience redness, swelling, tenderness, or discomfort at the surgical site during the first days after surgery. Participants undergoing elective open inguinal hernia repair will be randomly assigned to receive either an ozonated oil-impregnated dressing or a standard sterile dressing after the operation. The main outcome is the level of wound inflammation measured on the third day after surgery. Other outcomes include wound temperature, pain levels, cosmetic healing, and wound-related problems during the first 30 days. The ozonated oil used in this study is a CE-certified medical product that is already used in routine wound care. This pilot study aims to provide preliminary data to help determine whether ozonated oil dressing may improve early wound healing compared with standard care.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • Adults aged 18 to 75 years
  • ASA physical status I-III
  • Scheduled for elective, unilateral open inguinal hernia repair
  • Able to provide written informed consent

Exclusion Criteria8

  • Emergency inguinal hernia (incarcerated or strangulated)
  • Recurrent inguinal hernia
  • Concomitant surgical procedures during the same operation
  • Immunosuppression or long-term systemic steroid use
  • Use of anticoagulant or antiplatelet therapy
  • Known bleeding disorders
  • Active dermatologic disease at the surgical incision site
  • Pregnancy

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Interventions

DRUGozonated oil

Ozonated oil-impregnated sterile gauze is applied topically to the surgical incision immediately after skin closure. The dressing is changed once daily for the first 48 hours postoperatively, followed by standard wound care according to institutional routine.

OTHERStandard Sterile Dressing

A standard sterile dry dressing is applied to the surgical incision after skin closure and removed within 24-48 hours postoperatively. Subsequent wound care is continued according to routine institutional practice.


Locations(1)

Dr. Ali Rıza Erdoğan Private Practice Office

Niğde, Niğde Province, Turkey (Türkiye)

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NCT07328698


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